Responsibilities:

Leads Quality Management Systems (QMS):  Implements, maintains, and improves QMS processes, ensuring compliance with regulations and Elanco standards. Provides technical guidance and training to the QMS team. Oversees budgets, authors the Site Quality Plan, and drives continuous improvement initiatives. Manage Audits and Inspections:  Prepares for and manages regulatory inspections and corporate audits. Ensures inspection readiness, reviews QMS records, and drives timely completion of corrective actions. Provides Quality Governance:  Develops and implements governance processes (, Quality Lead Team, Deviation Review Board). Identifies and analyzes quality risks, reporting the overall state of QMS control to senior leadership. Oversees Training and Development:  Develops and executes training programs for the Elanco QMS. Ensures training program effectiveness within the QMS department. Identifies professional development opportunities for self and team. Leads Investigations and CAPA:  Reviews and approvals of manufacturing and Quality department investigations, ensuring compliance, root cause identification, and effective corrective and preventative actions (CAPA). What You Need to Succeed (minimum qualifications): Education: Bachelor’s degree in science-related discipline. Experience: 10+ years’ experience in a regulated pharmaceutical/vaccine manufacturing environment. 5+ years of experience in people management including direct & indirect reports. Thorough knowledge of cGMP/GLP regulatory requirements for Biotech products, including direct experience with external audits (USDA, FDA, EMEA). Previous experience in department oversight (organizational, budgeting, strategy). What will give you a competitive edge (preferred qualifications): Advanced degree highly preferred Demonstrated proficiency in lean/5S/six sigma methodologies Ability to set up partnerships with regulatory authorities to resolve quality & compliance issues. Versatility in conflict resolution, problem solving and working with cross functional teams. Sound business acumen and strategic mindset Additional Information: Location: Fort Dodge, Iowa: On-Site Work Environment – Excellent relocation package available!